Quadsense
The FDA filing describes QUADSENSE as a system for comparing forces in the patellofemoral joint during total knee surgery. It includes a patella sensor, adjustment shims, a control puck,…
The FDA filing describes QUADSENSE as a system for comparing forces in the patellofemoral joint during total knee surgery. It includes a patella sensor, adjustment shims, a control puck, and a touchscreen Panel PC running QUADSENSE software.
The sensor records medial, lateral, superior, and inferior loads during range-of-motion trials, and the Panel PC displays readings in real time. The stated use is as a comparative force-measurement tool during primary total knee arthroplasty where the patella is resurfaced.
Listed Item
Single use sensor
Sensor and Readout
The FDA indications passage states that the sensor is sterile and for single-patient use.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Immetech Industrial Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Eventum Orthopaedics Ltd, United Kingdom |
|---|---|
| FDA product code | ONN |
| Device type | Intraoperative Orthopedic Joint Assessment Aid |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K241298 |
| Record published | 2025-01-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 20 to 80 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 10 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SE001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Verasense | Orthosensor, Inc. | 140 |
| Lantern | OrthAlign, Inc. | 24 |
| LinkStation Mini | Orthosensor, Inc. | 8 |
| Linkstation Mini Evaluation Kit | Orthosensor, Inc. | 8 |
| Verasense for Stryker Triathlon | Orthosensor, Inc. | 6 |
| Verasense for Zimmer Biomet Persona | Orthosensor, Inc. | 6 |
| Lantern ASC | OrthAlign, Inc. | 4 |
| eLIBRA® | Synvasive Technology, Inc. | 2 |
| Verasense for Exactech Equinoxe Reverse | Orthosensor, Inc. | 2 |
| Lantern Surgical Assistant | OrthAlign, Inc. | 1 |
| Dongle Assembly | Eventum Orthopaedics Ltd | 1 |
| Quadsense Pro | Eventum Orthopaedics Ltd | 1 |
Showing 12 of 15. All products under Intraoperative Orthopedic Joint Assessment Aid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252524 | 2025-09-09 |
| K241298 | 2024-10-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.